Enforcement Report - Week of August 29, 2012
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Event Detail
| Event ID | 62751 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | Sunquest Information Systems, Inc. |
| City | Tucson |
| State | AZ |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2009-04-13 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and country of: Bahamas. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. | versions 2.4 and later | Class III | Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active. | 23 clients | Z-2243-2012 |
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